Artesunate has been recommended by the World Health Organization (WHO) as the first-line treatment for severe
malaria since 2010. It is not licensed in the United States but is available from CDC under an
investigational new drug (IND) protocol. During 2010-2012, a total of 19 cases of delayed
hemolytic anemia after treatment of severe
malaria with
artesunate were published in the peer-reviewed medical literature, but no such cases have been reported in the United States. CDC
Malaria Branch staff reviewed each published report of delayed
hemolysis after
artesunate use. Based on the pathogenesis of
malaria, the
hemolysis likely is a result of severe
malaria and not the treatment itself. However,
artesunate used in the United States is produced by the U.S. Army Medical Materiel Development Activity, and
artesunate used outside of the United States is not. An unrecognized difference might exist between the U.S.
artesunate and the
artesunate used elsewhere. Alternatively, cases of
artesunate-associated
hemolysis might have occurred in the United States but were not reported. To better assess these possibilities, CDC has amended the
artesunate IND protocol and now recommends that persons treated for severe
malaria with
artesunate be followed for 4 weeks
after treatment and evaluated for
hemolytic anemia.